Ignite Creation Date:
2025-12-25 @ 3:39 AM
Ignite Modification Date:
2026-02-18 @ 2:13 AM
Study NCT ID:
NCT01450202
Status:
COMPLETED
Last Update Posted:
2012-06-26
First Post:
2011-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-06', 'completionDateStruct': {'date': '2012-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-06-24', 'studyFirstSubmitDate': '2011-10-04', 'studyFirstSubmitQcDate': '2011-10-11', 'lastUpdatePostDateStruct': {'date': '2012-06-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-10-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'post-procedural pain', 'timeFrame': '3 months', 'description': 'The primary end point of the study was to assess post-procedural pain according to VAS scale'}], 'secondaryOutcomes': [{'measure': 'abdominal distention', 'timeFrame': '3 months', 'description': 'abdominal distention using measurement of patient waist circumferences'}, {'measure': 'ETCO2', 'timeFrame': '3 months', 'description': 'Measure ETCO2 using nasal cannula'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Carbon dioxide insufflation', 'Colonoscopy', 'Esophagogastroduodenoscopy', 'Bowel insufflation', 'Postprocedure pain', 'Pain Due to Certain Specified Procedures'], 'conditions': ['Pain']}, 'descriptionModule': {'briefSummary': 'Compared with performing each procedure individually, performing two combined procedures such as colonoscopy consecutive Esophagogastroduodenoscopy (EGD) cause more bowel gases, abdominal distension and post-procedure pain because of longer procedure time related to more bowel insufflated gas than one procedure. To the best of the investigators knowledge, there has been no randomized controlled trial of CO2 versus air for insufflations during combined two procedures, colonoscopy with consecutive EGD. And there are a few well randomized trials concerned CO2 insufflation in patients receiving sedation during colonoscopy.\n\nThe aim of the present study was to evaluate the efficacy of CO2 in reducing post-procedural abdominal pain and distension during colonoscopy consecutive EGD and to confirm the safety of CO2 insufflation when it is used during procedure in sedated outpatients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* outpatients between the ages of 18 and 70 years who are scheduled for colonoscopy with consecutive EGD\n\nExclusion Criteria:\n\n* age \\< 18 or \\> 70 years\n* pregnancy\n* breast feeding\n* chronic obstructive lung disease (COPD)\n* known CO2 retention and refusal to participate in the study'}, 'identificationModule': {'nctId': 'NCT01450202', 'acronym': 'COCE', 'briefTitle': 'Safety and Efficacy of Carbon Dioxide Insufflation During Colonoscopy With Consecutive Esophagogastroduodenoscopy in Reduction of Abdominal Pain in Sedated Outpatients', 'organization': {'class': 'OTHER', 'fullName': 'Inje University'}, 'officialTitle': 'Carbon Dioxide Insufflation During Colonoscopy With Consecutive EGD is Safe and Decreases Abdominal Pain in Sedated Outpatients: a Randomized, Double-blind, Controlled Trial', 'orgStudyIdInfo': {'id': 'Oct 2011-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Air insufflation, colonoscopy, esophagogastroduodenoscopy', 'interventionNames': ['Other: bowel insufflation gas']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CO2 insufflation, colonoscopy, esophagogastroduodenoscopy', 'interventionNames': ['Other: bowel insufflation gas']}], 'interventions': [{'name': 'bowel insufflation gas', 'type': 'OTHER', 'description': 'air insufflation, during colonoscopy and esophagogastroduodenoscopy', 'armGroupLabels': ['Air insufflation, colonoscopy, esophagogastroduodenoscopy']}, {'name': 'bowel insufflation gas', 'type': 'OTHER', 'description': 'CO2 insufflation, during colonoscopy and esophagogastroduodenoscopy', 'armGroupLabels': ['CO2 insufflation, colonoscopy, esophagogastroduodenoscopy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '612-030', 'city': 'Busan', 'country': 'South Korea', 'facility': 'Haeundae Paik Hospital', 'geoPoint': {'lat': 35.10168, 'lon': 129.03004}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Inje University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Eun Hee Seo, MD', 'investigatorAffiliation': 'Inje University'}}}}